The FDA has issued a warning letter to Pharmaceutical Laboratories and Consultants regarding several violations at the Illinois-based lab, including the presence of a microbrewery in its drug testing area.
The letter, issued in late August, cited “significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.”
The four issues cited include:
- Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
- Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a)).
- Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).
- Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).
Additionally, further inspection revealed shared space with non-drug operations:
In addition, our inspection revealed that you were operating a microbrewery in space shared with your contract testing laboratory where you test OTC drug products and components. You prepared and stored microbiology laboratory media in the same area you use to conduct brewery operations.
For example, our investigators observed a full fermenter located approximately ten feet from the space where media is prepared, warmed, and stored. A brewery employee was also preparing beer kegs in this area. In addition, laboratory test media, open beer bottles, and brewing materials were co-mingled within the same refrigerator.
These facility conditions pose unacceptable risks, including contamination of media during its preparation and compromised sample analyses. Conducting your testing operations in a space shared with a microbrewery is inappropriate and does not comply with CGMP. Your testing must be performed using facilities that are designed and controlled for drug laboratory testing.
The full letter from the FDA can be found on the FDA website.